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This study aims to examine the effects of Low-Intensity Focused Ultrasound (LIFU) on brain activity in patients with alcohol use disorder.
This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial. The study will assess target engagement of the ventral striatum after LIFU in patients with alcohol use disorder using resting state and task-based functional magnetic resonance imaging (fMRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VS LIFU/ VPL LIFU | Experimental | Participants will be assigned to receive VS LIFU during the first LIFU treatment session. |
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| VPL LIFU/VS LIFU | Active Comparator | Participants will be assigned to receive VPL LIFU during the first LIFU treatment session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Focused Ultrasound | Device | An inhibitory LIFU protocol that allows suppression of neuronal activity in the basal ganglia and thalamus will be used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of LIFU-related adverse events. | This will be assessed through monitoring for adverse events (AE) throughout the study. | Through study completion, an average of 5 weeks |
| Reward network activity in response to alcohol cues. | Reward network activity in response to alcohol vs. neutral cues before and after LIFU will be assessed using fMRI. | 3 visits over 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Borror, BS, CCRP | Contact | 415-514-6551 | TN2Lab@ucsf.edu | |
| Sierra Brandts, BS | Contact | 415-514-6551 | TN2Lab@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Khaled Moussawi, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35533835 | Background | Sarica C, Nankoo JF, Fomenko A, Grippe TC, Yamamoto K, Samuel N, Milano V, Vetkas A, Darmani G, Cizmeci MN, Lozano AM, Chen R. Human Studies of Transcranial Ultrasound neuromodulation: A systematic review of effectiveness and safety. Brain Stimul. 2022 May-Jun;15(3):737-746. doi: 10.1016/j.brs.2022.05.002. Epub 2022 May 6. | |
| 32221350 |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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This is a single-center, double-blind, controlled, randomized, complete block, 2-period crossover pilot trial.
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Due to the objectives of the study, the identity of LIFU treatments will not be known to research staff performing the data analysis or participants.
|
| Legon W, Adams S, Bansal P, Patel PD, Hobbs L, Ai L, Mueller JK, Meekins G, Gillick BT. A retrospective qualitative report of symptoms and safety from transcranial focused ultrasound for neuromodulation in humans. Sci Rep. 2020 Mar 27;10(1):5573. doi: 10.1038/s41598-020-62265-8. |
| 34198105 | Background | Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23. |
| 37779628 | Background | Mahoney JJ, Haut MW, Carpenter J, Ranjan M, Thompson-Lake DGY, Marton JL, Zheng W, Berry JH, Tirumalai P, Mears A, D'Haese P, Finomore VS, Hodder SL, Rezai AR. Low-intensity focused ultrasound targeting the nucleus accumbens as a potential treatment for substance use disorder: safety and feasibility clinical trial. Front Psychiatry. 2023 Sep 15;14:1211566. doi: 10.3389/fpsyt.2023.1211566. eCollection 2023. |
| 38670224 | Background | Martin E, Aubry JF, Schafer M, Verhagen L, Treeby B, Pauly KB. ITRUSST consensus on standardised reporting for transcranial ultrasound stimulation. Brain Stimul. 2024 May-Jun;17(3):607-615. doi: 10.1016/j.brs.2024.04.013. Epub 2024 Apr 25. |